Record mula sa primary source
Decision-gradeNaiskedyul ang advisory committee
MoonLake nag-iskedyul ng FDA Type B meeting para sa sonelokimab HS BLA package
Kinumpirma ng MoonLake ang Type B meeting sa FDA sa December 15, 2025 upang talakayin kung sapat ba ang kasalukuyang clinical evidence package mula sa VELA-1 at VELA-2 trials para suportahan ang BLA submission para sa sonelokimab sa hidradenitis suppurativa. Ang resulta ng meeting ang magtutukoy sa regulatory path at timing para sa planadong Q3/Q4 2026 BLA filing.
Mahahalagang fact
- Na-file
- Nob 5, 2025, 12:00 PM
- Kaganapan
- Naiskedyul ang advisory committee
- Direksyon
- Neutral
- Kumpanya
MLTXMoonLake- Asset
- sonelokimab
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Advisory committee · Dis 15, 2025 · Positibo
Sipi mula sa source
EX-99.1 2 moonlake-pressreleasexq320.htm EX-99.1 Document MoonLake Immunotherapeutics Reports Third Quarter 2025 Financial Results and Announces New Data from Clinical Trials of its Nanobody® Sonelokimab • Ended the third quarter with $380.5 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from a previously announced debt-facility, are expected to provide runway into the second half of 2027 • Reported results of its Phase 2 LEDA clinical trial in Palmoplantar Pustulosis (PPP) where sonelokimab (SLK) demonstrated clinically meaningful and statistically significant benefit • Reported an interim analysis of the long-term data from the VELA-1 and VELA-2 clinical trials in adults with Hidradenitis Suppurativa (HS), as well as an interim a
Higit pa tungkol sa asset na ito
Decision-grade
Hun 22, 2026
11:00 AM
MLTXMoonLakeMateryal
May 11, 2026
11:09 AM
MLTXMoonLake